Zileuton for Food Allergy
Investigation of Zileuton as a Novel Treatment to Prevent Anaphylaxis for Children and Adolescents With Food Allergies
Our proposed project will seek to determine if an oral medication called zileuton, which blocks the synthesis of inflammatory molecules called leukotrienes that are involved in allergic reactions, may be able to decrease absorption of food allergens and prevent severe food allergy reactions from occurring. Our study will measure levels of peanut in the blood before and after subjects consume an allergen they can tolerate and compare the results with and without administration of the study medication, zileuton. If our study shows that zileuton can decrease the absorption of a food allergen, this will allow us to see if this medication can be used to prevent anaphylaxis to food.
The goal of this proof-of-concept study is to determine whether zileuton inhibits food allergen absorption in children and adolescents with food allergy. The main questions it aims to answer are:
- Does zileuton administration impact food allergen absorption in children and adolescents with food allergies?
- What is the variability of food allergen absorption in children and adolescents with IgE-mediated food allergies?
Researchers will compare levels of peanut allergen proteins in the participants' blood with and without a dose of zileuton prior to a test meal of peanut protein.
- Visit 1 will involve a baseline blood draw, a test meal of peanut protein and a post-meal blood draw.
- Visit 2 will involve a baseline blood draw, a dose of zileuton before the test meal of peanut protein, and blood draws after the test meal.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Abigail Lang, MD, MSCI
- Número de telefone: "0", 76474 800-543-7362
- E-mail: AllergyResearchNurse@luriechildrens.org
Estude backup de contato
- Nome: Michelle Catalano, BS, LPN
- Número de telefone: "0", 76455 800-543-7362
- E-mail: MCatalano@luriechildrens.org
Locais de estudo
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Recrutamento
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Contato:
- Michelle Catalano, BS, LPN
- Número de telefone: "0", 76455 800-543-7362
- E-mail: MCatalano@luriechildrens.org
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Investigador principal:
- Abigail Lang, MD, MSCI
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Adolescent subjects ages 12-17
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Parent or guardian fluent in English
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Known IgE-mediated food allergy other than peanut
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Confirmed by clinical history of reaction to the food antigen plus
- positive skin prick testing and/or serum food-specific IgE AND
- confirmation of the food allergy diagnosis by a board-certified allergist
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Exclusion Criteria:
- A previous positive peanut specific IgE test or skin prick test, or a history of any allergic symptoms following peanut consumption
- Medical conditions known to affect the gastrointestinal tract
- Any history of hepatic disease or previous abnormal liver function tests
- Previous hypersensitivity or anaphylaxis to zileuton
- Current use of a medication known to interact with zileuton, such as theophylline, warfarin, or propranolol
- History of drug or alcohol abuse
- Use of any investigational drugs within 30 days of screening
- Initiation of allergen immunotherapy within 3 months prior to Visit 1 or a plan to begin therapy during the trial
- Use of leukotriene antagonists/modifier such as montelukast
- Pregnant persons
- Individuals with uncontrolled neuropsychiatric disorders
- Use of oral corticosteroids (OCS) within 2 weeks before screening or are scheduled to receive OCS during the study period for another condition
- Monoclonal antibody or immunosuppressive treatment within 3 months of screening
- Past or current medical problems which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may compromise the quality of the data obtained from the study
- Inability or unwillingness of a parent or guardian to give written informed consent or participant to give assent
- Non-English speaking participants
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Study treatment
Treatment with a single dose of Zileuton administered at Visit 2. |
Zileuton is available in 600 mg strength yellow-colored oval tablets. A single dose of 1200 mg zileuton ER (two 600 mg zileuton tablets) will be administered to each participant.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Inhibition of food allergy absorption by zileuton
Prazo: 1.25 hours pre-meal and 1 hour post-test meal (Visit 1, Baseline); 2.25 hours pre-test meal and 0.25, 0.5, 1 hour post-test meal (Visit 2, 7 days after Visit 1)
|
Comparison of serum peanut antigen levels pre- and post-peanut test meal will be performed in each participant for Visit 1 (baseline) and Visit 2 (with study drug) to determine absorption of peanut. Comparison of post-meal peanut levels with and without zileuton treatment in each participant will also be performed to see whether gut permeability to peanut changes with study drug administration. |
1.25 hours pre-meal and 1 hour post-test meal (Visit 1, Baseline); 2.25 hours pre-test meal and 0.25, 0.5, 1 hour post-test meal (Visit 2, 7 days after Visit 1)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Variability in allergen absorption in children and adolescents with food allergy
Prazo: 1.25 hours pre-meal and 1 hour post-test meal (Visit 1, Baseline); 2.25 hours pre-test meal and 0.25, 0.5, 1 hour post-test meal (Visit 2, 7 days after Visit 1)
|
Comparison of peanut antigen levels between participants to assess any variability in absorption of food antigens between individuals. |
1.25 hours pre-meal and 1 hour post-test meal (Visit 1, Baseline); 2.25 hours pre-test meal and 0.25, 0.5, 1 hour post-test meal (Visit 2, 7 days after Visit 1)
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00001016
- GIF00000023 (Número de outro subsídio/financiamento: Cures Within Reach)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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